Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT05827302
Eligibility Criteria:
Inclusion Criteria:
1. Male or female volunteers, at least 18 years of age at the time of screening visit;
2. Fluent in English and able to follow the instructions to use the Health Gauge AI-based Wearable Device;
3. Willing and cognitively able to sign informed consent
4. Interstitial lung disease, chronic obstructive pulmonary disease, pulmonary hypertension, or a healthy control
Exclusion Criteria:
1. Pregnancy;
2. History of active (clinically significant) skin disorders;
3. History of allergic response to plastic materials;
4. Subjects with electronic implants of any kind (e.g. pacemaker);
5. Broken, damaged or irritated skin or rashes near the sensor application sites;
6. Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.
Exclusion Criteria for healthy control only:
1. An active medical conditions for which they are on chronic treatment with drugs;
2. Shortness of breath (any sort);
3. Chronic cough;
4. Fatigue or difficulty sleeping.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05827302
Study Brief:
Protocol Section:
NCT05827302